Endoscopic Ultrasound-Guided Gastroenterostomy for Malignant Gastric Outlet Obstruction

July 21, 2022 updated by: Coordinación de Investigación en Salud, Mexico

Safety and Efficacy of Endoscopic Ultrasound-Guided Gastroenterostomy for the Treatment of Malignant Gastric Outlet Obstruction

Malignant gastric outlet obstruction is a very disabling complication of patients with gastric, duodenal, ampullary, pancreatic, or bile duct cancer and worsens their prognosis. Current treatments have reported a similar complication rate and higher mortality in surgically treated patients. Recently, the creation of endoscopic ultrasound-guided gastroenterostomy (EUS) has shown promising results in these patients. The aim of this research is to determine the safety and efficacy of EUS-guided gastro-enterostomy in the treatment of patients with malignant gastric outlet obstruction.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Malignant gastric outlet obstruction is a very disabling complication that occurs in 15% to 25% of patients with gastric, duodenal, ampullary, pancreatic, or bile duct cancer and worsens their prognosis. Roux-en-Y gastrojejunostomy is considered the gold standard treatment with technical success of 98.6% (97-3% -99.9%) and clinical success of 80.1% with patency of 169.2 (136.8-201.7) days. On the other hand, the technical success reported for self-expanding metal stents is 96.2% (94.1% vs. 98.4%), technical success is 79.4%, and patency at 6 months was only 57%. However, complications occur in a similar way in both forms of treatment (major complications in 6% and late complications in 17% in both, but mortality is higher in the group treated with Roux-en-Y gastrojejunostomy (29% vs. 17%). , p <0.001) Recently, the creation of endoscopic ultrasound-guided gastroenterostomy has shown success rates of over 90% in case series, but prospective studies evaluating the safety and efficacy of the procedure are lacking. The aim of this research to determine the safety and efficacy of EUS-guided gastro-enterostomy in the treatment of patients with malignant gastric outlet obstruction.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Raúl A Zamarripa Mottú, Fellowship
  • Phone Number: +528711733190
  • Email: raulzm735@gmail.com

Study Locations

  • Mexico
      • Mexico City, Mexico, 06700
        • Recruiting
        • Centro Medico Nacional Siglo XXI Hospital de Especialidades

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients of both genders over 18 years of age with gastric outlet obstruction syndrome secondary to stage III or more at gastric, duodenal or pancreatic cancer who are candidates for palliative treatment, who do not want surgical treatment.

    • Diagnosis confirmed as follows:

      • Histopathological report of cancer.
      • Simple and contrasted thoracoabdominal tomography.
      • Tolerance to oral feeding based on liquids only or null.

Exclusion Criteria:

  • Patients who do not accept the signing of the informed consent.

    • Postoperative patients with Roux-en-Y gastrojejunostomy.
    • Patients with large volume ascites.
    • Patients with malignant obstruction distal to the jejunal puncture.
    • Pregnant women.
    • Patients with a Karnofsky index less than 50 or an E.C.O.G. greater than or equal to 4 points.
    • Patients in whom any endoscopic procedure has been contraindicated for any reason.
    • Patients who want to undergo surgical treatment as an initial option.
    • Patients with malignant biliary obstruction without endoscopic treatment at the time of gastric outflow tract obstruction presentation.

Elimination Criteria:

  • Patients who undergo the endoscopic procedure but cannot be completed due to transmural invasion of malignancy, hemorrhage or inability to puncture the intestinal loop with any method described, puncture site> 2cm away from the gastric wall or inability to pass the guidewire through obstruction (unless direct technique is performed).
  • Patients who do not attend follow-up.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: EUS-guided gastroenterostomy in malignant gastric outlet obstruction
The patients with malignant gastric outlet obstruction will be confirmed as follows: Histopathological report of cancer, thoracoabdominal tomography and impaired tolerance to oral feeding (tolerance to liquids only or null).
Procedure: EUS-guided gastroenterostomy
First after an upper endoscopy is performed, a catheters passed throughout the endoscope channel and with x-ray verification, a guide wire is passed up to the third portion of duodenal loop. then small intestinal is filled with saline solution up to 1500cc and contrast solution. Then an endoscopic ultrasound examination will be carried out where a loop of the small intestine that is located less than 2 cm apart from the gastric wall will be looked for. Once the intestinal loop is identified a direct antegrade puncture will be performed with a luminal apposition prosthesis release system . Finally, correct position is verified with x-ray and we will look for any misplacement or leakage during this process or the presence of bleeding. Endoscopic treatment will be performed if necessary. Subsequently, the participants will go to monthly follow-up with clinical evaluation, laboratory and radiological test will be carried out until the participants dies.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of immediate adverse events in patients with gastric outflow tract obstruction treated by EUS-guided gastro-enterostomy.
Time Frame: Adverse events will be recorded during the first 24 hours of the procedure
To evaluate the proportion of patients that presents with bleeding , prostheses misplacement or perforation.
Adverse events will be recorded during the first 24 hours of the procedure
Incidence of early-term adverse events in patients with gastric outflow tract obstruction treated by EUS-guided gastro-enterostomy.
Time Frame: Adverse events will be recorded after the first day up to 30 days of the procedure
we will record the proportion of patients that presents with migration, clogging, stenosis at gastro-enterostomy site or leakage.
Adverse events will be recorded after the first day up to 30 days of the procedure
Incidence of mid-term adverse events in patients with gastric outflow tract obstruction treated by EUS-guided gastro-enterostomy.
Time Frame: Adverse events will be recorded from the first month up to the third month after procedure
we will record the proportion of patients that presents with migration, clogging, stenosis at gastro-enterostomy site or leakage.
Adverse events will be recorded from the first month up to the third month after procedure
Incidence of long-term adverse events in patients with gastric outflow tract obstruction treated by EUS-guided gastro-enterostomy.
Time Frame: Adverse events will be recorded after the third month of the stent placement up to study completion, an average of 6 months
we will record the proportion of patients that presents with migration, clogging, stenosis at gastro-enterostomy site or leakage.
Adverse events will be recorded after the third month of the stent placement up to study completion, an average of 6 months
Incidence of the correct stent placement for endoscopic ultrasound gastro-enterostomy anastomosis creation at the desired loop
Time Frame: During each procedure correct stent placement will be assessed
Technical success: We will determine the ability to place the stents in the desired loop and in a correct position.
During each procedure correct stent placement will be assessed

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement in tolerance to oral feeding assessed by the gastric outlet obstruction scoring system (GOOSS) in patients with gastric outflow tract obstruction treated by EUS-guided gastro-enterostomy
Time Frame: Immediately after the intervention/procedure/surgery and every month through study completion, an average of 6 months
Clinical success: Defined as an increase in tolerance to oral feeding, assessed by GOOSS: 0 = no/inadequate oral intake, 1 = liquids/thickened liquids, 2 = semisolids/low residue diet, 3 = unmodified diet. A higher score means a better outcome.
Immediately after the intervention/procedure/surgery and every month through study completion, an average of 6 months
Changes in quality of life assessed by the self-report health-related quality of life questionnaire in patients with gastric outflow tract obstruction treated by EUS-guided gastro-enterostomy.
Time Frame: Baseline and every month after the intervention/procedure/surgery through study completion, an average of 6 months.
Quality of life will be measured with the short form survey (SF-36 questionnaire). It consists of physical and mental component scores ranging from 0 to 100; a higher scores means a better outcome, a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Baseline and every month after the intervention/procedure/surgery through study completion, an average of 6 months.
Changes of functional impairment assessed by Karnofsky Performance Scale Index in patients with gastric outflow tract obstruction treated by EUS-guided gastro-enterostomy.
Time Frame: Baseline and every month after the intervention/procedure/surgery through study completion, an average of 6 months.
The Karnofsky Performance Scale Index allows patients to be classified as to their functional impairment. The lower scores means worst prognosis: 100-80 means that the patient is able to perform normal activities; 70-50 points means that the patient is unable to work; able to live at home and care for most personal needs, and 40-0 points means that the patient is unable to care for self; requires equivalent of hospital care and disease may be progressing rapidly.
Baseline and every month after the intervention/procedure/surgery through study completion, an average of 6 months.
Changes in functional status with Eastern Cooperative Oncology Group (ECOG) performance scale in patients with gastric outflow tract obstruction treated by EUS-guided gastro-enterostomy.
Time Frame: Baseline and every month after the intervention/procedure/surgery through study completion, an average of 6 months.
The ECOG Scale of performance status describes patients functionality. Lower points means best outcomes.0: fully active. 1: Restricted in some physical activities. 2: Capable of all self-care but unable to carry our any work activities, more than 50% of walking hours. 3: limited self-care, confined to bed or chair more tan 50% of walking hours. 4: Completely disabled. Totally confined to bed or chair. 5: Dead.
Baseline and every month after the intervention/procedure/surgery through study completion, an average of 6 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Coordinación de Investigación en Salud, Mexico

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2021

Primary Completion (ANTICIPATED)

October 1, 2022

Study Completion (ANTICIPATED)

December 1, 2022

Study Registration Dates

First Submitted

February 18, 2021

First Submitted That Met QC Criteria

March 18, 2021

First Posted (ACTUAL)

March 23, 2021

Study Record Updates

Last Update Posted (ACTUAL)

July 22, 2022

Last Update Submitted That Met QC Criteria

July 21, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R-2020-3601-298

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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